Ingestible Therapy Activator System and Method

ABSTRACT

An ingestible therapy activator system and method are provided. In one aspect, the ingestible therapy activator includes an ingestible device having an effector module to send an effector instruction and a responder module associated with a therapeutic device. The responder module may receive and process the effector instruction, resulting in a response by the therapeutic device. Examples of responses by therapeutic device include activating a therapy, deactivating a therapy, modulating a therapy, and discontinuing a therapy.

RELATED APPLICATION AND CROSS REFERENCE

This application claims the benefit of U.S. Provisional Application Ser.No. 61/114,442 filed on Nov. 13, 2008, the entire disclosure of which isincorporated herein by reference.

FIELD OF THE INVENTION

The present invention relates generally to medical therapy systems,devices, and methods. More specifically, the invention relates tosystems, devices, and methods for activation and/or modulation ofvarious medical therapies using an ingestible electronic device.

BACKGROUND

Multiple therapies exist for various health-related conditions, events,and defects. Such therapies may be implemented as implanted devices,e.g., cardiac rhythm management devices, neuralstimulation/neuromodulation devices, intrathecal drug delivery pumps,and functional neuromodulation prostheses such as cochlear implants,retinal implants, and artificial joints, limbs and organs. Onceimplanted, however, such devices may not provide the functionality tofacilitate controlled activation or modification.

In one example, a neural stimulation device may deliver pain-controltherapies to the spinal column, yet the neural stimulation device maynot be activated on demand. Stated differently, the neural stimulationdevice is always activated after implantation. As a result, the patientmay be subjected to neural stimulation, as well as its associatedunwanted side effects, at times when such therapy is not needed.

In another example, a neural modulation device such as a spinal cordstimulator may provide therapeutic benefit for pain, yet the rate ofstimulation may not be adjustable to align stimulation to the patient'slifestyle, e.g., a higher intensity during high activity periods and alower intensity during low activity periods. As a result, the patientmay need to restrict activities which do not conform to the stimulationintensity to receive optimal therapy results or suffer diminishedtherapy results when engaged in non-conforming activities.

Therefore, it would be desirable to have systems, devices, and methodsfor controlling therapies, for optimizing therapy results, and forenhancing patient treatment without having limitations placed on thepatient.

SUMMARY

The present disclosure includes a system for providing instructions to atherapeutic device. The therapeutic device can be any type of device,such as a cardiac therapeutic device, a neural stimulation device, anintrathecal drug delivery pump, a gastrointestinal device; and a neuralstimulation prosthesis. The system includes an ingestible unit and aresponder module. The ingestible unit includes an output or effectormodule that provides an effector instruction to the responder module.The responder module receives and processes the effector instruction andcommunicates the effector instruction to the therapeutic device to alterthe operation of the therapeutic device.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1 illustrates an ingestible activator environment including aningestible therapy activator.

FIG. 2 illustrates the ingestible therapy activator of FIG. 1 in greaterdetail.

FIG. 3 illustrates an ingestible device of the therapy activator of FIG.2 in greater detail.

FIG. 4 illustrates an effector module of the ingestible device of FIG. 3in greater detail.

FIG. 5 illustrates an effector instruction of the ingestible therapyactivator of FIG. 2 in greater detail.

FIG. 6 illustrates a responder module of the ingestible therapyactivator of FIG. 2 in greater detail.

FIG. 7 illustrates a therapeutic device of the ingestible activatorenvironment of FIG. 1.

FIG. 8 illustrates ingestion and activation of a therapeutic device viaan ingestible therapy activator.

DETAILED DESCRIPTION

Generally, the invention may provide for controlled activation and/ormodulation of an implanted medical device or related therapy. Moreparticularly, the invention includes use of an ingestible device toeffect activation and/or modulation of devices/therapies related toimplantable medical devices. Typically, the patient controls ingestionof the ingestible device. Ingestion of the ingestible device results inactivation and/or modulation of the patient's medical device and/ortherapy. Alternatively, ingestion of the ingestible device mayinactivate or discontinue a device/therapy. Thus, as a novel andbeneficial result of the invention, the patient and/or other party maycontrol at will various outcomes associated with various implantedmedical devices and related therapies based on the provision ofingestible devices and a healthcare provider or other party may controla supply, e.g., by prescription, of the ingestible devices.

Use of an ingestible device to activate and/or modulate therapy may havebroad potential application for any implanted device or therapy, toinclude cardiac rhythm management; neural stimulation and/orneuromodulation (sometimes collectively referred to herein as “neuralstimulation”); intrathecal drug delivery pumps and therapies; andfunctional neuromodulation prostheses such as cochlear implants, retinalimplants, and artificial joints, limbs and organs.

Activation of therapy includes, for example, activation of a device toinduce and event or condition. For example, activation of a gastricbanding device having neural stimulation electrodes may induce increasedsatiety and/or induce an improvement in the rate of stomach motility.Further, the ingestible device may activate the band portion of thegastric banding device, e.g., constricting the band. If the ingestibledevice is taken prior to ingestion of a meal, the patient may controlappetite, satiety, caloric intake, and ultimately influence weightmanagement results, etc.

Certain aspects may be directed to in-body therapies and may include,for example, implantable medical devices. The term “implantable medicaldevice”, as used herein, refers to a device configured to be positionedat least partially on a living body, at least partially in a livingbody, or a combination thereof.

For example, the implantable medical device may include a lead havingvarious electrode configurations communicably associated with controllercircuitry, a power source, etc. More particularly and illustratively,the implantable medical device may comprise one or more leads withmultiple in-line segmented electrode satellites, wherein each electrodeis independently controllable and power/data wire(s) for multiplexingthe multiple segmented electrode satellites. Various configurations ofdevices which may be used in conjunction with this invention may bedescribed/disclosed in the PCT application no. PCT/US2003/039524published as WO 2004/052182; PCT application no. PCT/US2005/031559published as WO 2006/029090; PCT application no. PCT/US2005/046811published as WO 2006/069322; PCT application no. PCT/US2005/046815published as WO 2006/069323; PCT application no. PCT US2006/048944published as WO 2007/075974; U.S. application Ser. No. 11/939,524published as US 2008-0114230 A1.

Various configurations of devices which may be used in conjunction withthis invention may be described/disclosed in PCT application serial nos.PCT/US2008/052845 published as WO/2008/095183 and PCT/US2006/016370published as WO/2006/116718. Each of the aforementioned applications isherein incorporated by reference in its entirety. The aforementionedconfigurations are for illustrative purposes only and that various othercomponents and configurations are possible.

FIG. 1 illustrates an ingestible therapy activator environment 100including an ingestible therapy activator 102. In various aspects, theingestible therapy activator environment may be a living being, such asa mammalian being, including a human being. In various aspects, theingestible therapy activator 102 may communicably interoperate with oneor more therapeutic devices 108, e.g., in-body devices such as implanteddevices or other devices. The communicable interaction may result inactivation and/or modulation of the therapeutic device, 108, e.g.,immediate activation of the therapeutic device 108, delayed activationof the therapeutic device 108, immediate modulation of the therapeuticdevice 108, delayed modulation of an activity associated with thetherapeutic device 108, etc. In this manner, a patient may control atherapeutic outcome via ingestion of the ingestible therapy activator102.

FIG. 2 illustrates the ingestible therapy activator 102 of FIG. 1 ingreater detail. In various aspects, the ingestible therapy activator 102includes an ingestible device 200 having an effector module 202, aneffector instruction 204, and, optionally, a responder module 206. Uponingestion of the ingestible device 200, the effector module 202 maysend, e.g., transmit, the effector instruction 204. The effectorinstruction 204 may be received, e.g., via the responder module 206, andmay cause activation and/or modulation of a therapeutic device 108and/or a therapy associated with the therapeutic device 108. Further,multiple ingestible devices 200 may be ingested simultaneously or inclose temporal proximity, and each of the multiple ingested ingestibledevices 200 may interact with one or more therapeutic devices 108.

The ingestible device 200 includes any device, component, hardware,and/or software, and combinations thereof, capable of ingestion by aliving being and further capable of mechanical, electronic, and/or incommunicable interoperation with the effector module 202, describedhereinafter.

To illustrate, the ingestible device 200 may include, comprise, beintegrated into, etc., a placebo structure. The placebo structure maycomprise, for example, a capsule, a pill, etc. To further illustrate,the ingestible device 200 may include, comprise, be integrated into,etc. an ingestible medication. The ingestible medication may comprise,for example, a capsule, a pill, liquid, etc., and may be prescribed,over-the-counter, etc.

Various ingestible devices 200 may comprise, include, be integratedwith, etc., devices such as those described in the PCT/US2008/052845published as WO/2008/095183 and PCT/US2006/016370 published asWO/2006/116718, the entire disclosure of which is incorporated herein byreference. Additionally, all references cited herein are herebyincorporated by reference in their entirety.

A pharma-informatics system described in PCT/US2006/016370, filed Apr.28, 2006, which includes compositions, includes systems and methods thatallow for the detection of the actual physical delivery of apharmaceutical agent to a body.

An Ionic Emission Module or Ingestible Event Marker (IEM) systemdescribed in PCT/US2008/52845, filed Feb. 1, 2008, and U.S. patentapplication Ser. No. 12/564,017, filed Sep. 21, 2009 (both of which areincorporated herein by reference) include an IEM and a personal signalreceiver. Aspects of the IEM include an identifier, which may or may notbe present in a physiologically acceptable carrier. The identifier ischaracterized by being activated upon contact with a target internalphysiological site of a body, such as digestive tract internal targetsite. The personal signal receiver is configured to be associated with aphysiological location, e.g., inside of or on the body, and to receive asignal of the IEM. During use, the IEM broadcasts a signal which isreceived by the personal signal receiver.

The IEM also includes two dissimilar materials deposited on two sides ofthe IEM to form electrochemical potentials and act as the cathode andthe anode to form a power source. The dissimilar materials may beseparated by a non-conducting material or skirt that amplifies thesignal through increasing the current path. More specifically, thedissimilar materials can be made of any two materials appropriate forthe environment in which the IEM will be operating. For example, whenused with the ingestible device the dissimilar materials may be any pairof materials with different electrochemical potentials that areingestible. An illustrative example includes the instance when the IEMis in contact with an ionic solution such as stomach acids, as shown inFIG. 8 below. Suitable materials are not restricted to metals, and incertain aspects the paired materials are chosen from metals andnon-metals, e.g., a pair made up of a metal (such as Mg) and a salt(such as CuCl or CuI). With respect to the active electrode materials,any pairing of substances—metals, salts, or intercalation compounds—withsuitably different electrochemical potentials (voltage) and lowinterfacial resistance are suitable. Additionally, a control module (notshown) is electrically coupled to each of the two dissimilar materialsin order to receive power and become activated as well control theconductance and hence the current path between the two dissimilarmaterial. The control module alters conductance between the dissimilarmaterials in a unique manner. By altering the conductance path betweenthe dissimilar materials, the control module is capable of controllingthe magnitude of the current through the conducting fluid/liquid thatsurrounds the IEM or ingestible device 200. This produces a uniquecurrent signature that carries or encodes the effector instruction andcan be detected and measured by a receiver, such as the responder module206, which can be positioned internal or external to the body.

A controlled activation ingestible identifier described inPCT/US07/82563, filed Oct. 17, 2007, includes ingestible compositionssuch as pharma-informatics enabled compositions. The controlledactivation ingestible identifiers include a controlled activationelement that provides for activation of the identifier in response tothe presence of a predetermined stimulus at a target site of interest.

FIG. 3 illustrates the ingestible device 200 of the therapy activator ofFIG. 2 in greater detail. More particularly, the ingestible device 200may be associated with various vehicles 300, e.g., placebo, medication,capsules, etc., as heretofore discussed. In various aspects, multipleingestible devices 200 may be associated with a single vehicle 300,e.g., two ingestible devices 200 may be included in a single capsule;three or more ingestible devices 200 may be affixed on/manufacturedwithin a pill, etc. In addition to the effector module 202, theingestible device may comprise, be wholly or partially integrated with,integral to, etc., various other components 302. Examples of variousother components 302 include modules for detection of physiologicalparameters of the subject. The effector module 202 comprises any device,component, hardware, and/or software, and combinations thereof, capableof receiving, processing, storing, generating, and/or communicating theeffector instruction 204 of FIG. 2. In various aspects, for example, theeffector module 202 may comprise an integrated circuit (IC),microcircuit, microchip, silicon chip, miniaturized electronic circuit,etc., having the processing capability to receive, generate, store,etc., and a means to forward, e.g., via a transmitter, etc., theeffector instruction 204.

FIG. 4 illustrates the effector module 202 of the ingestible device ofFIG. 3 in greater detail. The effector module 202 may comprise amicrochip 400, a power source 402, and a transmitter 404. The microchip400 may be included and/or be associated with various components, e.g.,software, storage devices, memory, processing instructions, etc.,necessary to receive, generate, perform signal processing, and/or storethe effector instruction 204.

The power source 402 may be variously configured, e.g., wet battery,etc. In one aspect, the power source 402 may be an incomplete powersource, which may be activated upon contact with a targetedphysiological site. Thus, the power source 402 gets activated, therebypowering the microchip 400. Stated differently, the power source 402 mayexploit electrochemical reaction in an ionic solution such as gastricfluid, blood, or other bodily fluids and some tissues.

Depending on the configuration of the ingestible device 200, the targetphysiological site or location may vary, where representative targetphysiological sites of interest include, but are not limited to: alocation in the gastrointestinal tract, such as the mouth, esophagus,stomach, small intestine, large intestine, etc. In certain aspects, theidentifier is configured to be activated upon contact with fluid at thetarget site, e.g., stomach fluid, regardless of the particularcomposition of the target site. In some aspects, the identifier isconfigured to be activated by interrogation, following contact of thecomposition with a target physiological site. In some aspects, theidentifier is configured to be activated at a target site, wherein thetarget site is reached after a specified period of time.

The microchip 400, in turn, forwards a signal incorporating the effectorinstruction 204 via the transmitter 404 to a destination, e.g., directlyto the therapeutic device 108, to the therapeutic device 108 via theresponder module 206, etc.

In various aspects, various modes of communication, channels ofcommunication, and combinations thereof may be used. In one example, theeffector instruction 204 may be communicated via a radio-frequency (RF)signal. In another example, the effector instruction 204 may becommunicated via conduction, e.g., using in-body electrical signals as acommunication vehicle. In still another example, the effectorinstruction 204 may be communicated via conduction to a receiver affixedexternally to the patient, e.g., the responder module, which in turn,communicates the effector instruction to one or more therapeutic devices108, e.g., implanted therapeutic devices via various modes ofcommunication. Thus, as can be seen, various combinations of intra-bodyand extra-body channels and various modes of communication may be used.

The effector instruction 204 comprises any means capable of carrying thefunctionality as heretofore described, e.g., instigating an activationand/or modulation resulting in activation/modulation of a therapeuticdevice and/or therapy associated with the therapeutic device.

FIG. 5 illustrates an effector instruction of the ingestible therapyactivator of FIG. 2 in greater detail. In various aspects, the effectorinstruction 204 comprises any one or a combination of softwareinstruction(s) 500, a signal 502, data 504, etc. Further, any or all ofthe foregoing may be variously embodied and may be communicated viavarious modes and channels, as heretofore discussed.

FIG. 6 illustrates the responder module 206, which comprises any device,component, hardware, and/or software, and combinations thereof, capableof receiving, processing, storing, generating, and/or communicating theeffector instruction 204. In various aspects the responder module 206may be directly associated with a therapeutic device 108, e.g., inmechanical communication with the therapeutic device 108. Examples ofsuch a responder module 204 include an instruction receipt and/orprocessing unit physically configured as a component of a cardiacdevice, a gastro-intestinal device, a lead device, an electrode device,etc.

In various aspects, the responder module 206 may be indirectlyassociated with the therapeutic device 108, e.g., may be in electricalcommunication with the therapeutic device 108 but not in mechanicalcommunication therewith. Examples of such a responder module 204 includean instruction receipt and/or processing unit physically configuredwith/as a receiver, e.g., a wearable receiver such as a patch receiver,discussed in PCT/US2008/52845, supra.

FIG. 6 illustrates a responder module of the ingestible therapyactivator of FIG. 2 in greater detail. In various aspects, the respondermodule 206 may comprise a receiver 600 to receive the effectorinstruction 204, a microchip 400 to process and/or store, etc., theeffector instruction 204, and, optionally, a transmitter 404 to forwardthe effector instruction onward.

The receiver 600, for example, may be dedicated, i.e., receive only theeffector instruction or may be universal, i.e., may receive signals,data, etc., in addition to the effector instruction. In the case of theuniversal receiver, such reception of multiple types of communicationsmay provide for comprehensive device functionality, e.g., a cardiacpacing device which receives a pacing signal and the effectorinstruction.

Referring now to FIG. 4, the microchip 400, for example, may performvarious processing activities with respect to the effector instruction.One example includes aggregating multiple effector instructions from oneor more ingestible devices. Another example includes aggregating datafrom other sources, e.g., other devices, with the effector instruction.Another example includes modifying the effector instruction based onother data. To illustrate, the responder module 206 may receive andstore data related to cardiac pacing from a cardiac device. For example,an effector instruction to slow the rate of the cardiac pacing from 70beats per minute to 60 beats per minute. When the effector instructionis received, the microchip may analyze the data and, based on the resultof the analysis, modify the effector instruction to slow the rate to 65beats per minute. (After analysis of the data, this rate may be foundpreferable to the 65 beats per minute, as initially contemplated.) Inthis manner, the responder module 206 and the effector module 202 mayco-operatively affect optimal therapies.

The transmitter 404, for example, may transmit the effectorinstruction(s) 204, data, or a combination thereof, to a destinationdevice, e.g., the therapeutic device 108. The communication modes andchannels may be of various types and combinations thereof, as heretoforediscussed.

The therapeutic device 108 may be any device capable of providing orfacilitating at least one medical therapy to a living being.Particularly, the therapeutic device 108 includes implantable devices.

FIG. 7 illustrates a therapeutic device of the ingestible activatorenvironment of FIG. 1. The therapeutic device includes for example,cardiac devices, lead devices, electrode devices, migraine devices,urinary devices, gastrointestinal devices, etc.

The therapeutic devices may be activated and/or modulated in variousways, e.g., mechanical actuation, electrical activation, combinationsthereof, etc. In one example of mechanical actuation, the effectorinstruction received by a gastro-intestinal device such as a gastricbanding device (GBD) causes the GBD to signal controller circuitryassociated with a clamping device of the GBD. The controller circuitry,in turn, generates the controls necessary to inflate the clampingdevice, thus constricting the esophagus which results in greatersatiety, reduced ability to ingest food, improved gastric motility, etc.

In one example of an electrical activation, the effector instructionreceived by an electrode device such as a neural stimulation device(NSD) causes the NSD to signal controller circuitry associatedtherewith. The controller circuitry, in turn, generates the instructionsnecessary to provide electrical stimulation via the electrodes, thusmasking pain, stimulating a cardiac contraction, etc.

FIG. 8 illustrates ingestion and activation of a therapeutic device viaan ingestible therapy activator. As illustrated, ingestion of aningestible therapy activator 200 by a human 800 results in activation ofthe ingestible therapy activator 200 by stomach fluids. Once activated,the ingestible therapy activator 200 transmits the effector instruction204 to controller circuitry 808 associated with a cardiac pacing device804. Upon receipt and processing of the effector instruction 204 by thecontroller circuitry 808, instructions are sent to the cardiac pacingdevice 804 that result in a change in the rate of pacing of the heartvia the cardiac pacing device 804. In this manner, the patient cancontrol, and ultimately optimize, certain features, aspects, andparameters of the patient's cardiac therapy.

Continuing with further illustrations of the foregoing, effectuation ofa neural stimulation device directed to migraine management, e.g.,electrical stimulation of neural regions associated with migraine pain,may result in pain avoidance or abatement. If the ingestible device istaken at the onset of migraine aura, i.e., a sensory disturbance thatoften precedes a migraine headache, the patient may completely avoid themigraine headache and the severe pain associated therewith.

Effectuation of a urinary therapeutic device having electrodes tostimulate a voidance activity, which may assist in regulation ofincontinence urges and issues.

Effectuation of an electrode device associated with penile erection mayresult in successful treatment of various impotence-related disorders,including erectile dysfunction.

Effectuation of various cardiac devices to activate/modulate cardiactherapies may result in any one or more of improved cardiac therapy,optimized cardiac therapy, diminished habituation, eliminatedhabituation, and avoidance of habituation.

Effectuation of an NSD associated with spinal cord stimulation prior tovarious physical activities may result in any one or more of improvedpain-control therapy, optimized pain-control therapy, diminishedhabituation, eliminated habituation, and avoidance of habituation.

As a skilled artisan will note, various aspects facilitate at least somemeasure of control by the patient of the therapy.

The foregoing illustrate a few simple examples of the beneficial resultsassociated the invention. The applications of the invention, as well asthe resultant beneficial results, are too numerous to exhaustively listherein.

Various aspects include steps for ingesting an ingestible device havingan effector module; sending an effector instruction via the effectormodule; and receiving and processing, via a responder module associatedwith a therapeutic device, the effector instruction, resulting in aresponse by the therapeutic device.

Various aspects include an ingestible therapy activator comprising aningestible device having an effector module and an effector instruction.

Various aspects include a kit comprising an ingestible therapy activatorand a therapeutic device. Further, kits may also include a respondermodule associated with at least one of the ingestible therapy activatorand the therapeutic device.

One or more aspects of the subject invention may be in the form ofcomputer readable media having programming stored thereon forimplementing the various methods, or various steps thereof. The computerreadable media may be, for example, in the form of a computer disk orCD, a floppy disc, a magnetic “hard card”, a server, or any othercomputer readable media capable of containing data or the like, storedelectronically, magnetically, optically or by other means. Accordingly,stored programming embodying steps for carrying-out the subject methodsmay be transferred or communicated to a processor, e.g., by using acomputer network, server, or other interface connection, e.g., theInternet, or other relay means.

It is to be understood that this invention is not limited to particularaspects described, and, as such, may vary. It is also to be understoodthat the terminology used herein is for the purpose of describingparticular aspects only, and is not intended to be limiting, since thescope of the present invention will be limited only by the appendedclaims.

Where a range of values is provided, it is understood that eachintervening value, to the tenth of the unit of the lower limit unlessthe context clearly dictates otherwise, between the upper and lowerlimit of that range and any other stated or intervening value in thatstated range, is encompassed within the invention. The upper and lowerlimits of these smaller ranges may independently be included in thesmaller ranges and are also encompassed within the invention, subject toany specifically excluded limit in the stated range. Where the statedrange includes one or both of the limits, ranges excluding either orboth of those included limits are also included in the invention.

Certain ranges are presented herein with numerical values being precededby the term “about.” The term “about” is used herein to provide literalsupport for the exact number that it precedes, as well as a number thatis near to or approximately the number that the term precedes. Indetermining whether a number is near to or approximately a specificallyrecited number, the near or approximating unrecited number may be anumber which, in the context in which it is presented, provides thesubstantial equivalent of the specifically recited number.

Unless defined otherwise, all technical and scientific terms used hereinhave the same meaning as commonly understood by one of ordinary skill inthe art to which this invention belongs. Although any methods andmaterials similar or equivalent to those described herein can also beused in the practice or testing of the present invention, representativeillustrative methods and materials are now described.

All publications and patents cited in this specification are hereinincorporated by reference in their entirety as if each individualpublication or patent were specifically and individually indicated to beincorporated by reference and are incorporated herein by reference todisclose and describe the methods and/or materials in connection withwhich the publications are cited. The citation of any publication is forits disclosure prior to the filing date and should not be construed asan admission that the present invention is not entitled to antedate suchpublication by virtue of prior invention. Further, the dates ofpublication provided may be different from the actual publication dateswhich may need to be independently confirmed.

It is noted that, as used herein and in the appended claims, thesingular forms “a”, “an”, and “the” include plural referents unless thecontext clearly dictates otherwise. It is further noted that the claimsmay be drafted to exclude any optional element. As such, this statementis intended to serve as antecedent basis for use of such exclusiveterminology as “solely,” “only” and the like in connection with therecitation of claim elements, or use of a “negative” limitation.

As will be apparent to those of skill in the art upon reading thisdisclosure, each of the individual aspects described and illustratedherein has discrete components and features which may be readilyseparated from or combined with the features of any of the other severalaspects without departing from the scope or spirit of the presentinvention. Any recited method can be carried out in the order of eventsrecited or in any other order which is logically possible.

Although the foregoing invention has been described in some detail byway of illustration and example for purposes of clarity ofunderstanding, it is readily apparent to those of ordinary skill in theart in light of the teachings of this invention that certain changes andmodifications may be made thereto without departing from the spirit orscope of the appended claims.

Accordingly, the preceding merely illustrates the principles of theinvention. It will be appreciated that those skilled in the art will beable to devise various arrangements which, although not explicitlydescribed or shown herein, embody the principles of the invention andare included within its spirit and scope. Furthermore, all examples andconditional language recited herein are principally intended to aid thereader in understanding the principles of the invention and the conceptscontributed by the inventors to furthering the art and are to beconstrued as being without limitation to such specifically recitedexamples and conditions. Moreover, all statements herein recitingprinciples, aspects, and aspects of the invention as well as specificexamples thereof, are intended to encompass both structural andfunctional equivalents thereof. Additionally, it is intended that suchequivalents include both currently known equivalents and equivalentsdeveloped in the future, i.e., any elements developed that perform thesame function, regardless of structure. The scope of the presentinvention, therefore, is not intended to be limited to the exemplaryaspects shown and described herein. Rather, the scope and spirit ofpresent invention is embodied by the appended claims.

1-12. (canceled)
 13. A system for providing instructions to atherapeutic device, the system comprising: an ingestible devicecomprising: a housing; and an effector module physically associated withthe housing for providing an effector instruction, wherein theingestible device provides the effector instruction to the effectormodule upon activation in response to occurrence of a desired event; anda responder module in communication with the therapeutic device forreceiving and processing the effector instruction, wherein the effectorinstruction alters at least an operation of the therapeutic device. 14.The system of claim 13, wherein the effector module comprises amicrochip, a power source, and a transmitter.
 15. The system of claim13, wherein the ingestible device comprises at least one of an RFIDunit, an antenna, and a coil to communicate the effector instruction.16. The system of claim 13, further comprising an ingestible medicationphysically associated with the ingestible device.
 17. The system ofclaim 13, further comprising a placebo structure physically associatedwith the ingestible device.
 18. The system of claim 13, furthercomprising a receiver physically associated with the responder module.19. The system of claim 13, wherein the receiver is selected from agroup consisting essentially of a receiver adapted to be removablyaffixed to a living being, a handheld device, an implantable receiver,and a remote device.
 20. The system of claim 13, wherein the respondermodule is physically associated with the therapeutic device.
 21. Asystem for providing instructions to a therapeutic device, the devicecomprising: a support structure; and an effector module physicallyassociated with the support structure for providing an effectorinstruction, wherein the device provides the effector instruction to theeffector module upon activation in response to occurrence of a desiredevent; and the effector module communicates the effector instruction forreceipt by a responder module in communication with a therapeuticdevice, wherein the responder module is operable to process the effectorinstruction for alteration of at least an operation of the therapeuticdevice.
 22. The system of claim 21, wherein the effector modulecomprises a microchip, a power source, and a transmitter.
 23. The systemof claim 21, wherein the ingestible device comprises at least one of anRFID unit, an antenna, and a coil to communicate the effectorinstruction.
 24. The system of claim 21, wherein the ingestible devicecomprises a power source.
 25. The system of claim 21, further comprisingan ingestible medication physically associated with the ingestibledevice.
 26. The system of claim 21, further comprising a placebostructure physically associated with the ingestible device.
 27. Thesystem of claim 21, wherein the effector instruction comprises at leastone of a software instruction, a signal, and data.
 28. The system ofclaim 21, further comprising the responder module and the therapeuticdevice.
 29. The system of claim 28, wherein the responder modulecomprises a receiver, a microchip, and a transmitter.
 30. The system ofclaim 28, wherein the therapeutic device comprises a cardiac device. 31.The system of claim 30, wherein the therapeutic device comprises atleast one of a lead device, and electrode device, a migraine device, aurinary device, and a gastrointestinal device.
 32. An ingestible therapyactivator comprising: an ingestible device having an effector module; aneffector instruction generated by the effector module; and a respondermodule operable to process the effector instructor and, based on theeffector instruction, to generate an alteration of at least an operationof a therapeutic device.